K880991 is an FDA 510(k) clearance for the LASER OPTICAL CATHETER SYSTEM. This device is classified as a Laser, Surgical, Gynecologic (Class II - Special Controls, product code HHR).
Submitted by Medline Industries, Inc. (Englewood, US). The FDA issued a Cleared decision on May 25, 1988, 78 days after receiving the submission on March 8, 1988.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4550.
| 510(k) Number | K880991 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 08, 1988 |
| Decision Date | May 25, 1988 |
| Days to Decision | 78 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | — |
| Product Code | HHR — Laser, Surgical, Gynecologic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4550 |